# FDA recall Z-2525-2020

> **TeDan Surgical Innovations LLC** · Class II · device recall initiated 2020-05-15.

## Product

3COR DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.

## Reason for recall

Lack of pouch seal.  Product is labelled as sterile.

## Distribution

Worldwide distribution - U.S. Nationwide distribution including in the states of: AZ, CA, FL, GA, HI, IL, MA, MI, NC, NH, NJ, NY, NV, PA, PR, TN, TX, and WA . The countries of  Australia, Canada, France, Philippines, Taiwan, U.A.E., and United Kingdom.

## Key facts

- **Recall number:** Z-2525-2020
- **Recalling firm:** TeDan Surgical Innovations LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-05-15
- **Report date:** 2020-07-15
- **Termination date:** 2022-09-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Sugar Land, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2525-2020

## Citation

> AI Analytics. FDA recall Z-2525-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2525-2020. Source: US FDA. Licensed CC0.

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